Capricor Therapeutics Provides Regulatory Update on Deramiocel Program for Duchenne Muscular Dystrophy Following Type A Meeting
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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Source: GlobeNewswire
FDA and Capricor aligned on endpoints for HOPE-3 pivotal trialHOPE-3 pivotal trial completed; topline data expected mid-Q4 2025 to support BLA resubmissionCompany preparing to resubmit CRL response under the current BLAConference call and webcast scheduled for today at 8:30 a.m. ET SAN DIEGO, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced a regulatory update for its Biologics License Application (BLA) for Deramiocel, the Company’s investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD). This update follows a recent Type A meeting with the U.S. Food and Drug Administration (FDA) after the receipt of a Complete Response Letter (CRL) in July 2025. The goal of the Type A meeting was to establish a path toward potential approval of Deramiocel for the treatment of DMD. Key outcomes included: The HOPE-3
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News
- Capricor Therapeutics Announces Pricing of $150 Million Public Offering of Common Stock [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics prices $150M stock offering [Seeking Alpha]Seeking Alpha
- Capricor Therapeutics Announces Pricing of $150 Million Public Offering of Common StockGlobeNewswire
- Capricor Therapeutics Announces Proposed Public Offering of Common Stock [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics Announces Proposed Public Offering of Common StockGlobeNewswire
CAPR
Earnings
- 11/10/25 - In-Line
CAPR
Sec Filings
- 12/5/25 - Form 424B3
- 12/4/25 - Form 424B5
- 11/10/25 - Form 10-Q
- CAPR's page on the SEC website